Table 1

Characteristics of participants

N=988
Gender (M/F)366/622
Age (mean±SD)46.71±7.70
Trial arm (DMT/placebo)420/422
EDSS (median, range)6 (3–7.5)
SDMT (mean±SD)39.86±14.20
9HPT (mean±SD)35.81±19.62
EDSS progression confirmed at 3 months
(no. progressed/not progressed)
197/643
9HPT worsening
(no. worsened/not worsened)
177/244
SDMT worsening
(no. worsened/not worsened)
173/187
  • EDSS progression was defined as 1 point increase from a baseline EDSS score ≤5.5, or as 0.5 points from a baseline EDSS score >5.5, excluding all clinical visits within 30 days from an attack, and these scores were confirmed at 3 months.36 We estimated the 9HPT worsening as a 20% increase with respect to the baseline score (Lublin et al37; Tur et al36). We calculated the SDMT worsening as a 10% decrease with respect to the baseline score.38 39

  • DMT, disease-modifying treatment; EDSS, Expanded Disability Status Scale; F, females; 9HPT, Nine-Hole Peg Test; M, males; SDMT, Symbol Digit Modalities Test.